. PROJECT SUMMARY (See instructions): The Clinical Trials Core Facility (CTCF) facilitates clinical research at the Case CCC by providing the highest quality infrastructure that includes nursing, regulatory, data management, quality assurance, budgeting and contracting, informatics, and education functions for research staff and investigators. With its expertise in coordinating and managing complex studies including early phase and investigator-initiated trials, the CTCF plays a central role in Case CCC clinical research. The CTCF resides within the Case CCC Clinical Research Office (CRO). The CRO oversees and coordinates all clinical research administration components including the CTCF, Protocol Review and Monitoring System, Data and Safety Monitoring, and Protocol Specific Research Support. As a consortium cancer center, the CTCF oversees operations at the affiliated medical centers, through the Clinical Trials Unit (CTU) at each hospital which is responsible for the development, conduct, and management of specific clinical trials. All training and audits are coordinated through the CTCF. The Medical Director of the CTCF oversees integration of activities of the consortium member CTUs, with standardization ensured through a single policies and procedures manual and monthly meetings of the Clinical Research Operations Committee (C-ROC) and its subcommittee, the Clinical Trials Working Group (CTWG). In 2011, 1,527 patients were enrolled onto Case CCC interventional trials, including 919 patients on therapeutic studies. Thirty-eight percent of accruals to therapeutic intervention studies were to investigator-initiated trials (peer-reviewed, institutional). The CTCF provides support for all cancer clinical trials, from protocol development through reporting of results. The Core also oversees use of the OnCore clinical trials database, ensuring timely maintenance of protocol status and patient accrual.